EPA Axes Panel Chair at Request of Chemical Industry Lobbyists

Saturday, March 15, 2008

EPA Axes Panel Chair at Request of Chemical Industry Lobbyists

At the request of a chemical industry lobbyist, the Environmental Protection Agency removed the chair of an expert peer review panel charged with setting safe exposure levels for a toxic fire retardant that contaminates human blood and breast milk, according to documents obtained by Environmental Working Group (EWG). After doing the industry’s bidding, EPA then retroactively stripped all of the chair’s comments from the panel’s published report and republished the altered document.

In a letter to the EPA, a lobbyist for the American Chemistry Council argued that the panel chair, Dr. Deborah Rice of the Maine Center for Disease Control and Prevention, should be thrown off the panel because she exhibited an “appearance of bias” when she represented her agency's position in favor of restricting uses of Deca in her testimony before the Maine legislature. EPA acquiesced and removed Dr. Rice from the panel. The Agency first tried to cover up its actions by stripping any mention of Dr. Rice and all of her comments from the original published review document, and reposting the altered document on the web with no indication that any changes had been made. Months later EPA officials issued a disclaimer that Dr. Rice had been removed for a “perception of a potential conflict of interest.” The omission of the chair’s comments from the review document could result in a significantly weaker safety standard for the chemical, which EPA intends to propose at the end of March 2008.

EPA’s sacking of Dr. Rice reveals a dangerous double standard where scientists and experts working for state or federal health agencies can be removed from EPA advisory panels simply because they express the views of their agency in public as a part of their job responsibilities. Meanwhile, numerous scientists with direct financial ties to the manufacturers of chemicals under review, or with publications and public statements touting the safety of chemicals they are evaluating, remain as active participants on these panels.

Deca is a developmental neurotoxin used in electronics and other consumer products, from a family of fire retardants known as PBDEs (polybrominated diphenyl ethers). The targeted expert, Dr. Deborah Rice, was the panel member most knowledgeable about Deca risks. A retired EPA scientist and life-long public servant, Dr. Rice co-authored an important study on Deca toxicity to the brain and nervous system during development. She also spearheaded a regulatory review mandated by Maine law, to investigate the feasibility of replacing Deca with less toxic chemicals. Her transgression, according to the industry complaint, was that in testimony before the Maine legislature, Dr. Rice displayed an “appearance of bias” simply by stating her agency’s position in support of state legislation to restrict Deca.

EPA Stacks Panels With Industry-Biased Scientists

EPA has institutionalized the practice of loading key public health advisory panels with individuals sympathetic to or employed by the chemical industry. EWG examined seven EPA panels established in 2007 that use non-EPA scientists to evaluate the agency's proposed safe daily exposure levels, or "reference doses,” for important commercial chemicals where the agency is concerned about human exposure. In this small snapshot we identified 17 individuals who were employees of companies that make the chemicals under review, scientists whose work was funded by industries with a financial stake in the panel outcome, or scientists who have made over-reaching public statements about the safety of the chemical in question.

To our knowledge, EPA’s decision to remove Dr. Rice as chair of the Deca review panel represents the first time EPA has kicked a scientist off any panel for expressing concern about a chemical's health risks. Removing panelists because they state their concerns about a chemical's toxicity, while promoting scientists with clear financial ties to the regulated industry, sends a dangerous signal that EPA will not tolerate the views of individuals who believe in precaution in the face of evidence that a chemical presents a legitimate health risk.

Chemical Industry Used Allies inside the Agency to Bump Panel Chair

The chemical industry’s trade association, the American Chemistry Council (ACC), submitted their demand for Dr. Rice’s removal to Dr. George Gray of EPA’s Office of Research and Development (ACC 2007). Before joining EPA Dr. Gray headed up an organization funded by the ACC called the Harvard Center for Risk Analysis, well-known for their studies and advocacy to dismiss concerns about chemical safety.

ACC acted on behalf of their Brominated Flame Retardant Industry Panel (BFRIP) in making their demands to EPA. Recent media reports reveal that other efforts by the Bromine Industry to keep Deca on the market have included hiring a lobbyist who also represented the tobacco industry and the National Association of State Fire Marshalls in advocating for increased use of chemical fire retardants in place of fire-safe cigarettes and other commonsense methods to reduce fire risk (Shin 2008).

Rice's Removal From the Panel Could Weaken the Safety Standard

EWG’s line-by-line comparison of the panel report before and after EPA stripped Dr. Rice’s comments from the document shows that the altered document is now missing major concerns relevant to Deca’s risks to humans, particularly infants, children, and other vulnerable populations. EPA’s failure to consider these points could substantially influence their decision on an appropriate safety standard for the chemical:

Dr. Rice noted that EPA had no scientific basis for its assumption that a single day of Deca exposure linked to brain damage in animal studies is the most critical period of vulnerability for animal and human brain development. EPA’s recognition of this data gap would result in an additional factor of safety applied to the Agency’s daily safe dose (the reference dose, or RfD). Now the panel’s recognition of the data gap and the Agency’s baseless assumption is completely missing from the panel review document.

Dr. Rice noted that Deca risks should be considered in tandem with risks from related PBDEs that are also common blood and breast milk pollutants. Since all congeners being evaluated show the same type of neurotoxicity, health risks from these fire retardants would be additive. This comment reflects a view of additive chemical risks widely accepted across the scientific community but absent from EPA’s proposed methods for assessing Deca risks. Because the agency removed her comments, the panel review document no longer reflects this important point. EPA’s failure to consider additive risks would result in a vastly less protective health standard for Deca.

The EPA Double Standard

Over the past seven years it has become common practice for scientists with conflicts of interest and well-known, pro-industry biases to serve on and even lead EPA advisory panels. Some examples include: Direct financial conflict – Scientists employed by the companies who make the chemicals under review. Dr. Robert Schnatter sits on EPA’s expert panel charged with producing an assessment of the cancer potential of the chemical ethylene oxide, a mammary carcinogen used as a fumigant and hospital equipment sterilizer. Schnatter works for ExxonMobil, a manufacturer of the chemical he is charged with reviewing. EPA chose Schnatter for the panel despite the obvious contradiction his appointment presents to their policy to “always make every effort to use peer reviewers who do not have any conflict of interest...” (EPA 2006). Public statements that could indicate bias. Dr. Rice was removed from the PBDE panel for making public statements indicating that she had formed an opinion about the safety of the chemical. Yet similar statements have been made by many other reviewers examining other chemicals, almost always to the effect that the chemical under review is safe. Consider Lorelei Mucci, of the Harvard School of Public Health, who sits on a panel slated to review EPA’s proposed revisions to the safety standard for acrylamide, a contaminant of baked and fried food (EPA SAB 2008). Dr. Mucci has made numerous public statements discounting the health risks of acrylamide. As just one example, in August 2007 she claimed in the media that “The intake of acrylamide, no matter how much is consumed, is not a breast-cancer risk factor” (Riddell 2007). At the time she made this statement, findings from laboratory and epidemiology (human) studies conflicted on this point. Just months after her statement, a new study found more than double the incidence of estrogen-related breast cancers among women with high exposures to acrylamide in food compared to women with lower exposures (Thonning 2008). For her history of similar statements, reports of Dr. Mucci’s work have been characterized by respected scientist Dale Hattis as “scientific overreaching” (Hattis 2003). Career consultants with a clear record of work to weaken health standards on behalf of industrial clients. EPA panel chair and industry consultant Dr. Betty Anderson secured a panel decision to support EPA’s proposed 3-fold weakening of the health standard for a plastics chemical and common human pollutant called dibutyl phthalate (DBP) (EPA 2006b). The year that Dr. Anderson reviewed EPA's draft standards, her employer, Exponent, was under contract with ACC's Phthalate Ester Panel to discredit a key epidemiological study that found everyday exposures to DBP were linked to reproductive system defects in baby boys (Exponent 2006). The next year Exponent released a defense of a phthalate used in children's toys funded by the Toy Industry Association (TIA 2007). In her work for chemical makers, Anderson clearly expressed her goal to weaken health standards. Memos written by Anderson and housed in the national tobacco library show that she lobbied EPA for a more than 3-fold weakening of health protections on behalf of R.J. Reynolds. She first designed work to “bolster our position that [safety factors] used by EPA… can be dropped” (Anderson 1999a), and then relayed her success to her client at Reynolds: “I believe EPA has conceded a 10-fold [safety] factor reduction to 3…” (Anderson 1999b). She also advocated for two types of studies that could further weaken health standards: “Both or either [type of study] could remove the factor of 3.” Remarkably, in that statement she is predetermining findings from studies she had yet to design (Anderson 1999b). In another example that illustrates the same type of conflict, frequent EPA consultants James Swenberg and Vernon Walker conduct industry-funded research to demonstrate that mutagenic chemicals do not cause cancer in humans. Their findings conflict with a wealth of established scientific evidence. Dr. Swenberg was a panelist for 1,1,1-trichloroethane, and both were consultants to the ethylene oxide panel. Scientists who consult to companies that make the chemicals under review. EWG’s review revealed that in 2007 EPA panels included at least 13 additional members whose employers have worked for or have been funded by companies who make the chemicals they are charged with reviewing. Industry consultants are inherently conflicted as panel members, since companies hire consultants who will represent what they consider to be their best interests. On panels, a consultant's support for strengthening health standards could compromise their chances to win contracts from chemical manufacturers, while their expressions of rationale for weakening health standards immediately raise their prospects for future contracts. It takes a unique consultant, one willing to risk losing future personal income, to support strengthening public health protections when it’s needed. Click here for detailed information about potential conflicts among industry consultants.

Recommendations

EWG calls on EPA to clarify their guidance with respect to public statements by panel members, and commit to a transparent process for resolving allegations of bias. In order to restore public confidence in the peer review process EPA must:

Reinstate Dr. Rice as the chairperson of the PBDE (Deca) expert review panel;

Remove the altered panel review document from public record and restore the original panel review document that included Dr. Rice’s comments; and

Promptly issue an updated health standard for Deca that adequately protects public health and that thoroughly considers Dr. Rice’s comments, including the issue of additive risks from multiple related fire retardants that widely contaminate the U.S. population.

However, EPA’s double standard for panel experts is much broader than the single panel assessing Deca health standards. In order to maintain the integrity of peer review for agency decisions, EPA must:

Collect information regarding all current and past financial ties between prospective panelists and companies who might benefit from weakened safety standards;

Create formal, public records of their determination of bias for each scientist selected as reviewer; and

Release all records of any similar instances in which EPA has removed panel members or published altered versions of EPA expert reviewer submissions.

EWG is submitting a Freedom of Information Act request to EPA to turn over all documentation collected by the Agency or its contractors regarding potential conflicts of interest for external review panels during 2006 and 2007. This includes a request for files documenting inter-agency discussions of potential conflicts for individual reviewers, including Dr. Rice, and any communication with outside parties (like ACC) about the external reviewers.